Archive for the 'States' Category

While all eyes in the health policy community have been fixed on the Supreme Court, awaiting its decision in King v. Burwell regarding the legality of premium tax credits granted through the federally facilitated marketplaces, a case of arguably equal importance has been quietly awaiting a decision. On March 31, 2015, a closely divided Supreme Court decided in Armstrong v. Exceptional Child Center, Inc. that health care providers cannot sue state Medicaid programs in federal court to enforce 42 U. S. C. §1396a(a)(30)(A) which requires states to “assure that payments are consistent with efficiency, economy, and quality of care” while “safeguard[ing] against unnecessary utilization of . . .care and services.”

Justice Scalia’s majority opinion, written for himself, Chief Justice Roberts, and justices Thomas and Alito, would have arguably swept away nearly a half century of Medicaid law and hold that lawsuits could not be brought by providers in federal court to enforce the requirements of the Medicaid program. A dissenting opinion, written by Justice Sotomayor for herself and Justices Kennedy, Kagan, and Ginsburg would have held that providers could have a cause of action under some circumstances to enforce the Medicaid law’s provider payment requirements against the states. Justice Breyer, the deciding vote for the majority, wrote a narrow opinion, joining Justice Scalia’s opinion only in part, leaving the law somewhat unsettled as to rights under the Medicaid program going forward.

Funding for the Children’s Health Insurance Program (CHIP) is now set to expire after September 2015. A new study, being released by Health Affairs as a Web First, and also appearing in its April issue, examines the availability and cost of dependent coverage for children through employer-sponsored plans. Such plans would be the primary pathway to affordable coverage for more than half of all children losing CHIP eligibility, insofar as access to employer-sponsored coverage through their parents can bar children from receiving Marketplace subsidies.

According to the study, 96.9 percent of enrollees in employer-sponsored plans had access to dependent coverage. The additional cost would vary — as much as $7,252 per year for workers with one dependent child and $11,829 for those with two or more dependent children. The study also found that adding dependent coverage could cost many families more than 8.05 percent of their income, qualifying them for hardship exemptions from buying coverage.

As a result, many children once covered by CHIP would no longer be insured. This study is thought to provide the first estimates documenting variations across employers in the marginal costs to families adding children to employer-sponsored plans.

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

The relationship between medicine and capital punishment has been a persistent feature of this past year in health law, both at the level of medical ethics and Supreme Court review.

Our story starts in Oklahoma, where the execution of Clayton Lockett was botched on April 28, 2014. NIH bioethicist Seema Shah described the events in question:

Oklahoma was administering a new execution protocol that used the drug midazolam, a sedative that is often used in combination with other anesthetic agents. Oklahoma had never used this drug in executions before; in fact, only a few states had experience with using the drug in lethal injection. Florida had previously used this drug in lethal injections, but with a dose five times higher than what was indicated in Oklahoma’s protocol. If the execution had gone as planned, Clayton Lockett would have first received midazolam; been declared unconscious, then received vecuronium bromide (a paralytic/neuromuscular blocking agent that would restrict his movements), and finally received potassium chloride (the drug likely to end his life). A few minutes after officially being declared unconscious, Lockett mumbled statements including the word, “Man.” He “began breathing heavily, writhing, clenching his teeth and straining to lift his head off the pillow.” Prison officials prevented the witnesses from seeing the rest of the proceedings by closing the curtains. The Department of Corrections then called off the execution and unsuccessfully tried to resuscitate Lockett, and Lockett eventually died of a heart attack more than 45 minutes after the execution began. Although a Department of Corrections official stated that Lockett’s veins “exploded,” an autopsy examination performed by a forensic pathologist hired by death row inmates appears to contradict official reports. This report concluded that even though prison officials decided to inject the drugs into Lockett’s femoral vein (which is a more difficult and risky procedure), Lockett’s surface and deep veins had “excellent integrity.” Another execution that was scheduled to occur that same night has now been stayed for six months, pending an investigation into Mr. Lockett’s execution.

On July 23, 2014, Arizona encountered a problem with the same drug in the execution of Joseph Wood, wherein the condemned inmate allegedly gasped for almost two hours before dying.

The executions have prompted two important but different kinds of responses. In this post I write about the role of medical ethics and the U.S. Supreme Court’s response.

The findings from a recent synthesis of the literature about the effectiveness of prevention initiatives focused on reducing the risk of Type 2 diabetes among high-risk populations (people already obese or inactive or diagnosed as having prediabetes) are largely encouraging.

The synthesis includes a comprehensive and systematic review of the medical, diabetes, and public health literature for evaluation studies of interventions published between 2002 and 2013. The search was undertaken using medical subject headings and keywords related to diabetes and its risk factors.

A number of interventions—such as the National Institutes for Health’s Diabetes Prevention Program and the Group Lifestyle Balance Program—focused on helping people eat better and become more physically active are effective in reducing the risk of diabetes onset. Robust studiesshow that these interventions work even better than medication to prevent diabetes.

Anticipating the upcoming Supreme Court decision on King v. Burwell, which could halt health insurance subsidies available through the federal exchange, Republican Senators Richard Burr and Orrin Hatch joined with Representative Fred Upton to propose a comprehensive replacement for the Affordable Care Act (ACA). The Patient Choice, Affordability, Responsibility, and Empowerment Act, or Patient CARE Act, is modeled on a proposal of the same name offered last year by Senators Burr, Hatch, and Tom Coburn, who has retired from the Senate. The Burr-Hatch-Upton plan, like its predecessor, adopts consumer-based reforms of the insurance market, modernizes the Medicaid program, and makes other changes intended to lower cost and increase choices.

In an earlier post, we described in detail the provisions of the Burr-Coburn-Hatch bill. In this post, we discuss how the Burr-Hatch-Upton plan differs from the earlier proposal. We also discuss the impact of the new proposal on health insurance coverage, premiums, and the federal budget based on a new analysis from the Center for Health and Economy (H&E), a non-partisan think tank focused on producing informative analyses of trends in U.S. health care policy and reform ideas. We conclude by commenting on the direction Republicans are likely to take in reforming the health system in the aftermath of a Supreme Court decision in the King v. Burwell case.

Oral health is an important but often overlooked part of health and insurance coverage. State Medicaid and the Children’s Health Insurance Program (CHIP) are required to cover children’s dental services (and children’s access to care has been improving over the last ten years), but coverage for adults is optional. As noted in a recent Health Affairs GrantWatch Blog post, only about 15 states offer extensive coverage for adult dental services in Medicaid.

Medicare does not cover most dental services. And most private dental coverage is offered through stand-alone dental products that are separate from medical plans. Overall, this has resulted in more than 2.5 times as many Americans going without dental coverage as medical coverage.

Inadequate access to dental care is costly. Many low-income individuals turn to the emergency department as their primary and only source of care for oral health needs. The American Dental Association estimates that emergency room visits for avoidable oral health-related visits cost the U.S. health care system as much as two billion dollars per year. A recent Narrative Matters feature in Health Affairs (“Navigating Veronika”) highlighted the steep barriers that low-income individuals can face in navigating the dental safety net and finding a provider who will treat them, even when Medicaid covers the costs of care.

Second, CMS and the Internal Revenue Service released updates regarding the issuance of corrected 1095-A forms. The 1095-As are the forms that exchanges are providing to individuals who received premium tax credits for 2014; they are supposed to help individuals reconcile the advance premium tax credits they received for 2014 with the tax credits they should have received.

Over the last three decades, the US has taken important steps to reduce financial barriers to health insurance coverage for low and moderate-income children. These steps began with the Medicaid expansions for children in the 1980s and early 1990s, which were followed by the creation of the Children’s Health Insurance Program (CHIP) in 1997. Most recently, Congress reauthorized CHIP in 2009 and enacted the Affordable Care Act (ACA) in 2010.

With open enrollment closed for 2015 and the Departments having finalized the Benefit and Payment Parameters Rule and Letter to Issuers for 2016, we have entered the Spring Affordable Care Act regulatory doldrums. Reports, minor regulations, guidances, and court decisions continue to appear, however. Two appeared on March 16. This post addresses the final wraparound coverage excepted benefits rule, and a report on health insurance coverage and the ACA (technical appendix here), both released on March 16, 2015.

The wraparound coverage rule creates a new category of excepted benefits. The concept of excepted benefits was created by the Health Insurance Portability and Accountability Act of 1996 and is carried forward in the ACA. Excepted benefits plans provide benefits that resemble in some way the health benefits that have been regulated by HIPAA and are now regulated by the ACA, but are more limited or are more tangential to medical care. These include benefits that are not generally medical benefits but do afford some medical coverage (auto liability, workers’ compensation); health coverage that is not medical coverage (dental, vision, long-term care); benefits that are not coordinated with medical benefits (specific disease coverage, fixed dollar indemnity coverage); and coverage that is supplemental to medical coverage (such as Medicare supplement policies). Additional specific conditions must be met for some of these benefits to qualify as excepted benefits.

Excepted benefits are generally not subject to Affordable Care Act requirements, such as the ban on dollar coverage limits or preexisting conditions clauses. But excepted benefit coverage explicitly does not qualify as minimum essential coverage. An individual who has only excepted benefit coverage and does not qualify for a shared responsibility requirement exception must still pay the individual mandate penalty. Large employers that offer only excepted benefits may have to pay the employer responsibility penalty, but individuals offered only excepted benefits by their employers are not disqualified from receiving premium tax credits to purchase individual coverage through the marketplaces.

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

Brittany Maynard’s highly publicized decision to end her life under Oregon’s Death With Dignity law has given a new face to the American right to die movement. It is that of a young, attractive, athletic newlywed, who would not have considered herself as having a stake in the movement until the day she learned a brain tumor was the cause of her severe headaches. She was terminally ill and faced a future of six months of increasing pain, debilitation, and severe seizures before dying.

A video of Maynard’s story produced by the non-profit advocacy organization Compassion and Choices has reached many millions of viewers. Extended coverage of her decision-making process by People Magazine resulted in record numbers of hits to the publication’s website. During her illness, Maynard moved from California to Oregon and on November 1, 2014 took barbiturates to end her life. In her memory, her husband and mother have become prominent activists in the effort to legalize physician aid-in-dying (PAD).

Is all of this likely to advance the PAD movement and, if so, through what legal processes?

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at so-called Right-to-Try laws. For patients with serious, potentially life-threatening diseases, current federal regulations offer two routes to gain access to experimental drugs not yet approved by the Federal Drug Administration (FDA): participation in a clinical research trial, or, if not possible, applying to the FDA for use of a drug under the expanded access (also known as compassionate use) program.

While the FDA has approved nearly all of these applications, the process is widely thought to be overly cumbersome. Since last year, five states have enacted their own Right-to-Try laws, with the aim of giving critically ill patients the treatments they seek. This health policy brief provides background on the federal regulations of expanded access and the recent involvement by many states.

Despite all the media hubbub and intense scrutiny, we didn’t learn all that much from the oral argument in King v. Burwell. The four liberal justices—Ginsburg, Breyer, Sotomayor, and Kagan—clearly believe that an exchange established “for” or “in” a state by the federal government is the same as an exchange “established by the state” (or at least that it’s ambiguous and the tie goes to the IRS). Justices Scalia and Alito—and presumably the silent Thomas—equally believe that words mean what they say.

So the case, as expected, turns on the views of Chief Justice Roberts and Justice Kennedy, who gave very little away. Indeed, I’ve never seen John Roberts so quiet at an oral argument—holding his cards so close that they risk being permanently imprinted on his vest—while Anthony Kennedy was characteristically inscrutable. In other words, 4-3 in the government’s favor with two wild cards.

That’s exactly what everyone knew going into the argument, and 85 minutes later if anyone tried to tell you that they knew what the outcome would be, they were engaging in spin or wishful thinking. To put an even finer point on it: whichever side you thought had the better chance of winning, downgrade your expectations to 50-50.

The resolution of King v. Burwell boils down to a simple point. A majority of the Supreme Court is willing to interpret the language of the Affordable Care Act. It is unwilling to rewrite that language.

It is all about four words: Whether “established by the state” in one section of the ponderously long, hastily passed health reform law renders low-income residents of states that have not created their own insurance exchanges but participate in federal exchanges ineligible for federal tax credits. If this is indeed the law, many middle-class families will be unable to afford coverage, residents of states that rely on federal exchanges will pay billions to the IRS for the benefit of those living elsewhere, premiums in those exchanges will rise as enrollment of healthy individuals drops, and the ACA will be unable to achieve its undisputed core purpose of health insurance for all Americans.

In contrast to the media cacophony leading up to yesterday’s hearing in the Supreme Court, the oral arguments themselves were clear and lawyerly. They were also undramatic. Most of the Justices knew where they stood, forcing plaintiff’s counsel Michael Carvin – who spoke first – to hear answers from the bench more often than he was asked actual questions. The Court’s willingness to listen had increased by the time Solicitor General Donald Verrilli took the podium on behalf of the government, and he proved himself an organized and articulate presenter. The only jurists not revealing their positions were Justice Kennedy, who challenged both lawyers on several points, and Chief Justice Roberts, who said little except to maintain order and decorum. (Justice Thomas famously refrains from participating in oral argument, but usually votes with Justice Scalia.)

The March 4, 2015 oral argument in King v Burwell, which will determine whether millions of low- and moderate-income Americans will continue to have access to affordable health insurance coverage, revealed a United States Supreme Court very much in play. In this climate, observers inevitably are paying heightened attention to each of the many parries and thrusts that unfolded over more than an hour of rapid give-and-take between the Justices and the lawyers, as they battled over the meaning of 4 words in a 1000-page statute.

Perhaps no exchange will receive more attention than the one between Justice Anthony Kennedy and Michael Carvin (representing the challengers) that took place approximately 5 minutes into his argument. It was Justice Sotomayor who actually kicked things off with the following observation:

The choice the state had was to establish [an] Exchange or let the Federal government establish it. . . .That was the choice. If we read [the statute] the way you’re saying, then we’re going to read a statute as intruding on the Federal-State relationship, because then the States are going to be coerced into establishing their own Exchanges. . . Tell me how that is not coercive in an unconstitutional way? And if it is coercive in an unconstitutional way [isn’t there] a primary statutory command that we read a statute in a way where we don’t impinge on the basic Federal-State relationship?

Editor’s note: Watch Health Affairs Blog for more posts on King v. Burwell and the Supreme Court oral arguments in the case by Tim Jost and others.

The Supreme Court justices had a lively discussion today during arguments in King v. Burwell about who Congress intended to get health insurance subsidies and under what conditions.

The central question is whether the Internal Revenue Service had the authority to write a rule authorizing subsidies to go to millions of people in the 37 states now operating under federal exchanges.

The plaintiffs say the language of the law is clear: Subsidies are allowed in “an Exchange established by the State under [section] 1311of the Patient Protection and Affordable Care Act.” It doesn’t just say this once, but nine times in various linguistic forms.

Editor’s note: Watch Health Affairs Blog for more posts by Grace-Marie Turner and others on King v. Burwell and the Supreme Court oral arguments in the case.

One March 4, 2015, the United States Supreme Court heard oral arguments in King v. Burwell. As every reader of this Blog knows, the issue in the case is whether the Internal Revenue Service rule that allows the federally facilitated marketplaces to grant premium tax credits is valid.

If it is not, millions of individuals in the 34 states served by the FFMs will lose their tax credits. Without the credits, they will no longer be able to afford health insurance. The cost of insurance to those remaining in the nongroup market will rise precipitously, causing even more Americans to lose coverage. As the number of uninsured increases, providers will bear an increased burden of uncompensated care. A decision for the plaintiffs, that is, will be disaster for the American health care system.

The challengers argue that this is a result Congress intended. They contend that the subsection of the Affordable Care Act dealing with the calculation of premium tax credits limits the credits to individuals enrolled in an “Exchange established by the State.” The government argues that this is a term of art — that Congress intended this phrase to include the federally facilitated exchanges that the ACA requires the Department of Health and Human Services to create as a fallback where the states elect not to operate their own exchange. Dozens of other provisions of the ACA support the government’s position.

The Supreme Court has spoken by a 6-3 vote, with Justice Anthony Kennedy writing an opinion for the Court joined by Chief Justice Roberts and Justices Breyer, Ginsburg, Sotomayor, and Kagan. In a strong, clear voice, the Court upheld the enforcement of a major federal statute against a state entity that had failed to embrace federal policy with respect to health care. Although not formally a constitutional decision, the Court’s interpretation of congressional intent played out against the backdrop of an important constitutional question: the permissible and appropriate balance between federal lawmaking and residual state authority. And it was the federal government’s seeming disregard of state sovereignty that led what has become the Court’s conservative rump – here Justice Alito, joined by Justices Scalia and Thomas – to write bluntly in dissent.

North Carolina State Board has nothing to do with “Obamacare,” but it may turn out to be the most important health care (and general public law) decision of the year. (Note to Pundits and Hypesters: King v. Burwell will only matter if the Court rules for the plaintiffs, and is unlikely to create enduring law even then. If the government wins, the case will soon be forgotten.) The Supreme Court’s ruling will give professional licensing boards throughout the country significant pause before adopting ad hoc policies that disadvantage competing professionals or non-professionals, and it should lead to a constructive conversation (and perhaps uniform or model legislation) regarding the accountability of self-regulatory bodies to actual state government. Its impact could be comparable to a major revamping of Joint Commission standards for health care facilities – low in visibility but dramatic in operational change.

In March, the U.S. Supreme Court is slated to hear King v. Burwell, a case that challenges the authority of the federal government to provide tax credits and other financial assistance to people who buy Affordable Care Act (ACA) coverage through the federal health insurance marketplace. The federal government runs the health insurance marketplace in 34 states where states chose not to set up a state-based exchange.

Estimates on how many people could lose tax credits in these 34 states vary widely from 4.5 million to 13 million. After talking to executives and lobbyists for health care related entities in 20 of the 34 states affected, I believe that about 6.5 million people who have tax credits in 2015 will lose them. The difference in these numbers will be important to policymakers, since politicians are likely to make decisions on how to respond to a Court ruling based on the actual number of their constituents who are receiving tax credits or other support.

In addition, the impact of a Court ruling will be affected by state action. Some observers have questioned whether states will set up exchanges if the Court eliminates tax credits from the federal exchange. These observers have said that establishing a state exchange is costly and time consuming and that most federal exchange states will not take this step. I argue in the following post that setting up a state exchange could be easy and inexpensive if the federal exchange operations are used.

With a new Congress, health care is once again an issue of tremendous scrutiny and debate. Many of the federal policy debates in 2015 will be largely symbolic, resulting in little more than tweaks to existing law.

However, health care policy is not just a matter for Congress to consider. A range of issues will play out in the states and the private sector, effectively shaping the future. Below are the top trends we’re watching this year.

The Year of Living Interoperably

From electronic health records (EHRs) to clinical measures and decision support tools, providers are inundated with new technologies that automate processes and capture new types of data. However, these systems are limited in their potential because they don’t all “talk” to one another. They’re locked away within proprietary technologies that render them the equivalent of an email account that only sends messages to people in your company, or a phone that only makes calls in your house.

On Wednesday, March 4th, the Supreme Court will hear the latest attack on the Affordable Care Act (ACA): the case King v. Burwell. The King petitioners allege that the Internal Revenue Service overstepped its authority by issuing regulations authorizing residents of states with federally run exchanges to access premium tax credits. The petitioners claim that Congress intentionally limited access to premium tax credits to residents of state-based exchanges as a way to encourage states to run their own exchanges.

In support, some state officials claim that they interpreted the law in this manner and that it impacted their state’s decision not to operate a state-run exchange. These assertions, like their analysis of the statutory language, fall flat under any serious scrutiny, however.

Between October 2012 and March 2013, with the support of the Commonwealth Fund, the Center on Health Insurance Reforms (CHIR) conducted a comprehensive review of publicly available information in 50 states pertaining to their decisions to operate either a state or federally run exchange.